Kornimate/medical-research-clean huggingface dataset:
trial of neoadjuvant endostar, docetaxel and epirubicin for patients with breast cancer

Conditions: Breast Cancer

Summary: this study was designed to determine the efficacy and safety of neoadjuvant docetaxel and epirubicin (de) with or without human recombinant endostatin (endostar) for breast cancer patients. the hypothesis of this protocol is that a combined angiogenesis inhibiting therapy to chemotherapy could further benefit breast cancer patients.

this is a multicenter, prospective, randomized, controlled phase ⅲ clinical trial. a total of 800 patients with core-biopsy confirmed breast cancer, stage ⅱa to ⅲc, and to be treated with neoadjuvant systemic therapy are eligible for entry into this study. patients will be allocated randomly to two groups to receive either 3 cycles of neoadjuvant de and endostar or 3 cycles of neoadjuvant de. all cases receive mammography, contrast-enhanced ultrasound (ceus), magnetic resonance angiography (mra), and positron emission tomography (pet) scanning pre- and post-neoadjuvant therapy, and then undergo surgical resection. the primary endpoint is clinical/pathological response. the clinical response will be evaluated according to recist criteria. the parameters of tumor metabolism and blood supply, as demonstrated by pet, mra and ceus, will be collected and analysed. the secondary endpoint is (1) the number of participants with adverse events, (2) quality of life scores, and (3) the number of adverse events reported during neoadjuvant therapy. in addition, the role of mammography, ceus, mra and pet for response evaluation, as well as the angiogenic profile and biological information involved in tumor response will be investigated.

Eligibility criteria:
inclusion criteria: * histologically confirmed invasive breast cancer (core needle biopsy for breast cancer diagnosis and fine needle aspiration for lymph node metastasis diagnosis) * stage ⅱa-ⅲc * age 18-70 * ecog performance status 0-2 * no evidence of distant metastasis * no previous therapy * normal hematologic function * left ventricular ejection fraction greater than 50 percent * no abnormality of renal or liver function * written informed consent exclusion criteria: * with allergic constitution or possible allergic reflection to drugs to be used in this study * any concurrent uncontrolled medical or psychiatric disorder * history of severe heart diseases, including congestive heart failure, unstable angina, uncontrolled arrhythmia, myocardial infarction, uncontrolled high blood pressure, or heart valve disease. * history of bleeding diathesis * being pregnant or nursing

Keywords: breast cancer neoadjuvant chemotherapy recombinant human endostatin (endostar) docetaxel epirubicin
study to investigate the safety and efficacy of alesion® in japanese paediatric patients with urticaria

Conditions: Urticaria

Summary: study to investigate the safety and efficacy of alesion® dry syrup under the proper use in daily clinical practice in japanese paediatric patients with urticaria


Eligibility criteria:
inclusion criteria: * all the patients who: * haven't treatment experience of epinastine product entered the survey; * have urticaria exclusion criteria: * alesion® dry syrup is contraindicated for the patients with history of hypersensitivity to any ingredients of alesion® dry syrup in package insert. however, it was unknown whether a patient is hypersensitive to the ingredients of the product in almost cases. and this survey was drug utilization study to observe actual use in any patients. therefore exclusion criteria are not set in the protocol
omega-3 fatty acids in treating patients with advanced prostate cancer

Conditions: Stage III Prostate Cancer

Summary: this phase i trial is studying the best way to give omega-3 fatty acids in treating patients with advanced prostate cancer. omega-3 fatty acids may slow disease progression and may be an effective treatment for patients with advanced prostate cancer

objectives: i. to conduct a pilot study of omega-3 polyunsaturated fatty acid (pufa) (omega-3 fatty acid) supplementation in a group of patients with advanced prostate cancer to assess the dose of omega-3 pufa necessary to achieve an omega-6 to -3 ratio of 1:1 on an individual basis and to assess the clinical impact of omega-3 supplementation on disease progression outline: patients receive long-term omega-3 polyunsaturated fatty acid (pufa) supplementation orally (po). after completion of study treatment, patients are followed up at 1, 6, and 12 months.

Eligibility criteria:
inclusion criteria: disease is currently controlled with androgen ablation therapy androgen ablation is expected to continue for at least 1 year has been treated with androgen ablation therapy for at least 1 month stable or decreasing prostate-specific antigen (psa) on androgen ablation therapy stable or no visible metastatic disease on imaging eastern cooperative oncology group (ecog) functional status of at 0 or 1 exclusion criteria: eligible for local intervention with surgery or radiation increasing serum psa on hormonal ablation radiographic evidence of progression of disease on hormonal ablation current or history of second malignancy previously treated with chemotherapeutic agents previous history of intermittent androgen therapy gastrointestinal (gi) disease that impacts absorption of nutrients
detecting colorectal cancer with liver metastatic lesions using novel precise imaging tools

Conditions: Liver Metastasis Colon Cancer

Summary: this study will demonstrate the diagnostic utility of psma pet among patients with crc with liver metastasis.


Eligibility criteria:
main inclusion criteria: 1. the participants can voluntarily sign informed consent forms 2. the participants are male/female over 20 years old. 3. the participant is currently undergoing cancer staging based on the previous pathological diagnosis of colorectal cancer 4. the participants are confirmed liver metastasis by ct, abdominal ultrasound, mri, and fdg pet/ct within 30 days before receiving psma-pet/ct. 5. who performance status ≦ 2 points 6. the participants can lie on table for two hours during psma-pet/ct scanning. main exclusion criteria: to improve the accurate interpretation of pmsa-pet imaging and reduce the occurrence of related-drug adverse events, the participants will be excluded by following below criteria. 1. the colorectal cancer participants was diagnosed other organs metastases with multiple organ metastases not only the liver. 2. the colorectal cancer participants have undergone any treate after diagnosis of liver metastasis. 3. the participants have suffered from liver dysfunction such as ast/alt ratio \>2、total bilirubin \>1.5 mg/dl within 6 months. 4. the participants suffered stage iv chronic kidney disease (egfr\<30 ml/min/1.73 m2) within 6 months. 5. the participants suffered acute kidney injury within 6 months. 6. the participants suffered trauma or fracture. 7. the participants are allergic to any radiopharmaceutical or imaging agent. 8. the participants are history of claustrophobia or are inability to remain quiet during the examination.

Keywords: liver metastasis psma pet
sonographic hysterosalpingography: oil vs water based media (show trial)

Conditions: Infertility

Summary: performing fluoroscopic hsg with oil based contrast medium has been shown to increase pregnancy rates in a subfertile population. this is a pilot study to test the efficacy of as well as the tolerability and safety of using lipid based oil medium for sonographic based hysterosalpingography (sono hsg) compared to water based contrast (i.e. normal saline) for women seeking fertility. the double blind study will randomize 56 women at the time of sono hsg in a 1:1 ratio to receive through the shg catheter either up to 10 cc of lipiodol uf® or normal saline. the investigators will collect subjective pain experience and follow the subjects for 6 months after the test for pregnancy and collect all adverse events during and after the procedure.


Eligibility criteria:
inclusion criteria: * eligible for sono hsg for fertility testing * in good general health * willing and capable of complying with the study procedures * at least one patent tube and no endometrial pathology on sono hsg * ready to undergo infertility treatment immediately after the test * not planning on ivf therapy in the next 6 mos exclusion criteria: * known tubal or endometrial (polyp, submucous fibroid, etc.) pathology * at high risk for tubal disease due to history of pelvic inflammatory disease * known hypersensitivity to lipiodol uf®or known allergy to iodine containing contrast media or shellfish * endometrial pathology on sono hsg requiring further evaluation (as per the performing physician) * bilateral tubal occlusion on sono hsg * unable to tolerate potential pain associated with the study. * requiring ivf due to severe male factor, known pelvic adhesions, etc. * couples with decreased male factor fertility rate (i.e., low sperm count or motility, i.e. less than 5 million/ml concentration on semen analysis
comparison of different inspiratory to expiratory ratios on respiratory mechanics and oxygenation in robot-assisted laparoscopic radical prostatectomy with steep trendelenburg position and pneumoperitoneum

Conditions: General Anesthesia Using Endotracheal Intubation

Summary: the steep trendelenburg position and pneumoperitoneum during laparoscopic surgery have the potential to cause an adverse effects on respiratory mechanics and gas exchange. previous studies have proposed that a prolonged i:e ratio ventilation improved respiratory mechanics and gas exchange. therefore, the aim of this study is to evaluate whether a prolonged i:e ratio ventilation improves gas exchange and respiratory mechanics in patients undergoing robot-assisted laparoscopic radical prostatectomy.


Eligibility criteria:
inclusion criteria: * adult male patients (20-90 years of age) scheduled for elective robot-assisted laparoscopic radical prostatectomy undergoing general anesthesia exclusion criteria: * patients with an abnormal airway anatomy, reactive airway diseases, chronic respiratory diseases, a history of coronary artery diseases, or heart failure * bmi \> 30 kg/m 2
detection of significant coronary artery disease by promising biomarker: a2a adenosine receptor (a2ar) assays

Conditions: Chronic Coronary Syndromes

Summary: transversal, national, multi-center study with progressive recruitment designed to assess the diagnostic accuracy of a2ar expression for the identification of significant obstructive cad (ffr\<0.8) of patients suspected of ccs compared to the gold standard. 1. to assess the diagnostic accuracy of the a2ar profile (i.e. kd/ec50) for identifying myocardial ischemia in patients with suspected ccs compared to the gold standard inducible myocardial ischemia. 2. to determine the best threshold value for a2ar expression for identifying significant obstructive cad (ffr\<0,8) in patients with ccs, and to estimate the diagnostic performances associated with the identified threshold 3. to determine the best threshold value for a2ar profile (i.e. kd/ec50) for identifying myocardial ischemia (see annex 2) in patients with ccs and to estimate the diagnostic performances associated with the identified threshold.


Eligibility criteria:
inclusion criteria: * man or woman aged ≥18 and \<90 years old; * must not be of child-bearing potential (≥1 year post-menopausal, contraceptive, or surgically sterile); * symptoms suggestive of ccs and intermediate ptp (15-85%) according to the diamond classification (2); * undergone at least one stress imaging test (annex 3) or an abnormal coronary computed tomography angiography (cta) with the recommendation to perform ica with ffr in all intermediate lesions; * non-contributive ecg (resting 18-lead); * normal echocardiography with left ventricular ejection fraction (lvef) \>50%; * cardiac troponin level \<99th percentile; * intended for an invasive strategy for ccs; * affiliated to or beneficiary of, a social security system; * signed written informed consent. exclusion criteria: persons referred in articles l.1121-5 to l.1121-8 and l.1122-2 of the public health code: * pregnant, parturient or breastfeeding woman * person deprived of liberty for judicial or administrative decision * person under psychiatric care * minor person (non-emancipated) * history of cad or known cad * suspected acute coronary syndrome (acs: annex 4) * inability to undergo adenosine testing * allergy to iodinated contrast media * bleeding diathesis * known significant bleeding risk according to physician judgment * severe hepatic failure (asat, alat\>3uln) * ischemic stroke within 1 month or a history of hemorrhagic stroke * bradycardia * platelet count \<100 g/l * hemoglobin \<10g/dl * major surgery or trauma within 10 days * life expectancy \<1 year * pre-test probability \ 85% * history and clinical examination suggesting non-cardiac chest pain * contraindication to coronary angiography * thyroid disorder * refusal to participate
fluid therapy during brain tumor resection in children

Conditions: Brain Neoplasms

Summary: fluid management of children during neurosurgery is not well established. hypotonic solutions, commonly still used in pediatric patients, may enhance cerebral edema and worse operative conditions. this study compares two different isotonic solutions administered perioperatively regarding acid base and fluid electrolyte disturbances.


Eligibility criteria:
inclusion criteria: * children undergoing elective craniotomy for brain tumor resection * informed consent form signed and dated by legal guardian and investigator * informed assent form signed by the patient if appropriate exclusion criteria: * uncontrolled intracranial hypertension * severe heart, kidney, or pulmonary disease * non-corrected electrolyte imbalance * allergy to the solution administered

Keywords: crystalloid solutions acid-base imbalance water-electrolyte imbalance
outcomes of partial pulpotomy treatment in cariously exposed teeth

Conditions: Deep Dental Caries

Summary: the aim of this clinical trial is to learn how successful biodentine and theracal pt dental filling materials are in treating deep tooth decay in adults. it will also provide information about post-treatment pain. the main questions it aims to answer are: do biodentine and theracal pt dental filling materials treat exposed tooth decay in participants? do they reduce the need for root canal treatment? after the application of biodentine and theracal pt dental filling materials to the participants, the pain and symptoms that cause pain may not decrease. in this case, the tooth may be treated with root canal treatment. the researchers will compare the clinical success of biodentine and theracal pt dental filling materials with each other. participants will undergo a single-session partial pulpotomy treatment with the dental filling materials mentioned above. clinical and radiographic follow-ups will then be performed at 3, 6 and 12 months, and records will be kept.


Eligibility criteria:
inclusion criteria: * • patient age should be between 18-50 years * should be able to give written informed consent * should have systemic status (asa 1) * should have permanent molar or premolar (lower and upper) root development * should be asymptomatic, deep (d3) or extremely deep (d4) caries * should give vital response in cold test and electric pulp test * should have teeth where the pulp is exposed with caries * should not have pain during palpation and percussion * should not have periodontal disease * should have restorable teeth * should have teeth without pulp necrosis, sinus tract or swelling/abscess * should have bleeding time less than 10 minutes * should be able to include a maximum of two teeth in a patient in the study (should be in different quadrants and there should be at least 2 weeks between treatment periods) exclusion criteria: * teeth with incomplete root development * severely affected teeth that do not respond to pulp sensitivity tests * teeth with signs and symptoms of irreversible pulpitis * teeth without signs of bleeding after communicating with the pulp chamber * teeth with pulp chamber open to the oral environment * teeth with periodontal pockets greater than 4 mm deep * teeth with suspected cracks or crown fractures that may be responsible for pulp pathology * teeth with uncontrolled bleeding * medically at-risk patients will be excluded from the study.

Keywords: deep dental caries partial pulpotomy calcium silicate-based material
chemoradiotherapy of capecitabine with or without oxaliplatin versus cisplatin-5-fu for esophageal squamous cancer

Conditions: Stage III Esophageal Squamous Cell Carcinoma; Stage II Esophageal Squamous Cell Carcinoma

Summary: a three-arm phase iii trial was started in oct. 2014. definitive chemoradiotherapy with cisplatin plus 5-fluorouracil is the standard in western countries in esophagus cancer. but in china because of its toxic reaction, most of patients stop the halfway. because low toxicity, the chemotherapy regimen of capecitabine with or without oxaliplatin are widely used in clinical. the purpose of this study is to confirm the difference of capecitabine plus with or without oxaliplatin over cisplatin plus 5-fluorouracil with definitive chemoradiotherapy for esophagus squamous cell carcinoma. a total of 249 patients will be accrued from china within 2 years. the primary endpoints are grade 3-5 aes and overall survival and the secondary endpoints include progression-free survival, response rate, pathologic complete response rate.

we plan to recruit the patients who were pathologically confirmed with esophageal squamous cell carcinoma from the oct 2014. the patients will be divided into three groups.experimental group 1 : single drug capecitabine and concurrent radiotherapy.experimental group 2: capecitabine plus oxaliplatin and concurrent radiotherapy. control group:cisplatin plus 5-fluorouracil and concurrent radiotherapy. to evaluate the adverse events and the overall survival of the three group. also observe the patient's progression-free survival, response rate, pathologic complete response rate.

Eligibility criteria:
inclusion criteria: * age 18-75years old * histologically proven squamous cell carcinoma of the esophagus the tumor was in t2-4n0-2m0 * the patients have not received the surgery or chemo-radiotherapy. * hb≥80g/l, absolute neutrophil count ≥1.5×109/l, plt≥90×109/l, * alt、ast≤2.5\*n,cr≤1.5\*n. * performance status score 0-2 exclusion criteria: * pregnant, lactating women * oxaliplatin or fluorouracil allergy or metabolic disorders * radiotherapy contraindications * history of organ transplantation * brain metastasis * the peripheral nervous system disorders * severe infection * oral capecitabine who have difficulty with,such as dysphagia,the activities of digestive ulcer, gastrointestinal bleeding * severe chronic diseases, such as, hepatopathy, nephropathy, respiratory disease,high blood pressure, diabetes. * other malignant tumor in recent 5 years.

Keywords: chemoradiotherapy， esophageal squamous cancer
platelet par-1 activation in health and diabetes

Conditions: Type 2 Diabetes; Healthy

Summary: platelet activation has been associated with bad events like heart attack and stroke. there are a variety of platelet activators that regulate how active a platelet is. we are interested in protease-activated receptors (par)-1. we are currently studying par-1 activation in persons with severe peripheral artery disease. we seek, through this project, to understand par-1 activation in persons without peripheral artery disease. as many patients with peripheral artery disease have diabetes, we will also evaluate par-1 activation in persons with type 2 diabetes. in addition we will assess the impact of the glucagon-like peptide (glp)-1 signaling pathway on platelet activation. levels of platelet activation will be determined using platelet aggregation experiments and assessment of platelet-monocyte aggregates in peripheral blood.


Eligibility criteria:
inclusion criteria: * healthy men and women ≥60 years of age or * type 2 diabetic men and women ≥60 years of age exclusion criteria: * active cancer * prior myocardial infarction, prior stroke, diagnosed peripheral artery disease * severe liver (cirrhosis, cancer, or end-stage liver disease), kidney disease (egfr \<30 cc/min). * pregnancy or lactation * active vasculitis * anticipated lifespan \< 2 years * current use of a doac
a clinical study to explore the efficacy and safety of hyperbaric oxygen in the neoadjuvant treatment of hormone receptor positive breast cancer patients

Conditions: Breast Cancers

Summary: the goal of this study is to explore the efficacy and safety of hyperbaric oxygen in the neoadjuvant treatment of hormone receptor positive breast cancer patients


Eligibility criteria:
inclusion criteria: 1. understood the study process, volunteered to participate in this study and signed an informed consent form 2. patients with histopathologically confirmed diagnosis of initial unilateral primary invasive breast cancer, occult breast cancer, inflammatory breast cancer and eczema-like carcinoma are excluded. 3. female, aged ≥ 18 years and ≤ 60 years. 4. patients who meet the inclusion criteria of neoadjuvant therapy to receive neoadjuvant therapy for breast cancer (locally advanced breast cancer (ajcc stage iii, except t3n1m0), or operable, but do not meet the conditions of breast conservation or axillary preservation (stage iia-iib and t3n1m0). 5. hormone receptor-positive breast cancer (luminal/her2-low (ihc 2+/fish-negative)). 6. ecog performance status 0-1. 7. lvef ≥ 55 per cent 8. adequate bone marrow functional reserve: white blood cell count ≥ 3.0 x 109/l, neutrophil count ≥ 1.5 x 109/l; platelet count ≥ 100 x 109/l; haemoglobin ≥ 90g/l; 9. ast, alt ≤ 2.5 times the upper limit of normal value, alkaline phosphatase ≤ 2.5 times the upper limit of normal value, total bilirubin ≤ 1.5 times the upper limit of normal value; serum creatinine ≤ 1.5 times the upper limit of normal value 10. for non-menopausal or non-surgically sterilised female patients: consent to contraception during treatment and for at least 7 months after the last dose of study treatment exclusion criteria: 1. have contraindications to hyperbaric oxygen therapy: lung disease (severe chronic obstructive airway disease, herpetic lung disease, acute or chronic lung infections, uncontrolled asthma, untreated pneumothorax), previous history of middle ear surgery, middle ear disease (eustachian tube dysfunction\\recurrent vertigo), eye disease (retinal detachment). 2. previous hyperbaric oxygen therapy. 3. distant metastases, including lymph node metastases in the contralateral breast and mediastinum. 4. malignancy other than radically treated basal or squamous cell carcinoma of the skin or cis of the uterine cervix within the last two years. 5. pregnancy or lactation. 6. uncontrolled hypertension, cardiac, hepatic, renal related diseases or other medical or psychiatric disorders. 7. major surgical procedures unrelated to breast cancer within 4 weeks prior to randomisation, or patients who have not fully recovered from such surgical procedures. 8. serious or uncontrolled infections that may interfere with study treatment or assessment of study results, including but not limited to active hepatitis virus infection, human immunodeficiency virus (hiv) antibody positivity, pulmonary infection, or other infections.